Candidate to provide statistical programming support and validation and help set specifications of analysis datasets, pooled datasets, statistical tables, summaries, figures and listing for Phase II-IV clinical trials. Employ standardized programs where applicable. Provide input into planning documents such as protocol, validation plan, and report analysis plan. Provide outputs for clinical study reports, integrated summaries and electronic submissions. Help respond to health authority inquiries for submitted dossiers. Establish and maintain sound working relationship and effective communications within biostatistics and statistical reporting and clinical research.
Skills:
Min 2-3 years of programming experience in HARP, the GSK programming environment is required.
At least 8 years work experience in a Statistical (SAS) programming role preferably supporting clinical trials or in the pharmaceutical industry (5 years for Masters in Mathematics, Statistics/Computer Science or health science graduates).
Advanced knowledge of / experience with SAS and other relevant programming software.
Proven experience in development of advanced MACROs with high programming efficiency; strong programming and problem-solving skills.
Proven experience in leading programmer support for multiple clinical trials and submission activities (or equivalent).
Expertise in programming according to specifications of analysis datasets, pooled datasets, listings, tables and figures for clinical trials and submission activities.
Working knowledge of database design/structures and basic statistics. Working experience in pooling analysis datasets across multiple clinical studies (or equivalent).
Good understanding of global clinical trial/project practices, procedures, methodologies.
Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
Oncology experience preferred
Strong expertise in CDISC on the submission bucket including CRT programming will be a definite plus.
Intermediate knowledge of office tools
Fluent English (oral and written)
Excellent in people interaction and be a collaborative team player.
Must have a BA/BS or equivalent experience in computer science, mathematics, statistics, life sciences, or related field(s).
Regards,
Akriti Gupta
Associate Recruiter(Scientific & Clinical Division)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3409 | Fax: 973.998.2599
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Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check: www.artechinfo.com